The Clinical Problem Solvers

NOVEMBER 22, 2021

Episode Learning Objectives: After listening to this episode learners will be able to… Understand the historical and present-day role of settler colonialism behind health disparities in Indigenous populations. Learn about the good and the ugly when it comes to the history of Indigenous Peoples.

Community 52

Community Patient-Centered Medical Student Medical 52

FDA Law Blog

OCTOBER 4, 2023

However, Judge Newman distinguished Michigan Bell from the present case because the Michigan law, which compelled participation by the plaintiff telephone companies, denied them of their right to a “fair and reasonable rate of return.” See Motion at 11. Order at 22. The drug was indeed selected on August 29, 2023.

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FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Clinic Clinical Practice Provider Utilities 64

FDA Law Blog

JANUARY 18, 2022

This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. Rather, it is meant to present various scenarios related to use of 3D?printed The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices.

Medical 98

Medical Manufacturing Healthcare Government 98

ABIM

MAY 18, 2025

This burden of the disease is being felt by patients and healthcare providers. I now know that the symptom I initially presented with—perianal fistulas—was a hallmark of Crohn’s disease. Worse yet, patients may avoid speaking up, even with their own providers, while suffering silently in pain. In the U.S.,

Diagnose 40

Diagnose Healthcare Diagnosis Physicals 40

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

Screening 119

Screening Primary Care Patient-Centered IT 119

FDA Law Blog

JANUARY 18, 2022

This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. Rather, it is meant to present various scenarios related to use of 3D?printed The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices.

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law Blog

SEPTEMBER 17, 2023

Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees. If FDA is slow in providing that list, it is fine to send a follow-up email requesting a list of FDA attendees in advance of the meeting. Be ready with backup options (e.g.,

Screening 59

Screening Transportation Provider Electronics 59

FDA Law Blog

AUGUST 23, 2021

The PhRMA Code is updated periodically to reflect changes in industry norms or, as is likely the case with the latest revision, in response to political pressure or increased scrutiny from the federal government. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ).

Specialization 52

Specialization Manufacturing Education Provider 52

FDA Law Blog

MARCH 1, 2023

The report recommends using a QMM rating that is shared throughout the market (purchasers, consumers, competing manufacturers) to provide manufacturers committed to QMM with a competitive advantage. In addition to providing some background on QMM, the FDA presented lessons learned from the QMM Program Pilots. By Holly N.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law Blog

JULY 6, 2021

Koblitz — FDA has long taken the position that a Complete Response Letter (“CRL”)—a letter sent when FDA has determined that it “cannot approve” a New Drug Application (“NDA”) or an Abbreviated New Drug Application (“ANDA”) “in its present form”—is not a final agency action and thereby not subject to challenge in Court. 314.110(c).

Government 52

Government IT Provider Manufacturing 52

BMJ

JULY 17, 2020

As previous research has found, providing factual information helps tremendously in addressing misconceptions and myths about infectious diseases, the latter of which can seriously undermine implementation of preventive measures. 新冠肺炎疫情报道中的信息呈现与媒体表现 [Information presentation and media performance during the COVID-19 outbreak].

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FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement.

Consulting 52

Consulting Manufacturing Provider Government 52

FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution. Deb along with fellow panelists Kyle Y.

Private Practice 52

Private Practice Government Specialization Management 52

FDA Law Blog

JANUARY 11, 2024

FDA provided each Boehringer and Pfizer the opportunity to present its interpretation of FIE expiration provisions, but FDA ultimately “decline[d] to adopt either Pfizer’s or BI’s proposed interpretation.” Notably, the purpose of the statute seemed to govern much of FDA’s interpretation.

Provider 59

Provider IT Manufacturing Complication 59

FDA Law Blog

APRIL 22, 2025

By law, DEA must provide you with notice and an opportunity for a hearing before it can take away your registration (or deny your application), so DEA will issue an Order to Show Cause, which explains the legal grounds for revoking or denying a registration and informs you of your right to challenge DEAs decision.

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Government Provider Consulting Manufacturing 52

Tiny Physician

FEBRUARY 15, 2022

Incompetent government The doctor-patient ratio of India is one of the worst in the world; we have 1 doctor for 1456 people against the WHO recommendation of 1:1000 [5]. There is only 1 government doctor for a population of 11,000 people and there is only 1 dental surgeon per 175,000 people [6]. are not met.

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Patient-Centered Government Referral Hospital 52

FDA Law Blog

OCTOBER 25, 2021

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

Manufacturing 52

Manufacturing Government Specialization IT 52

FDA Law Blog

JUNE 8, 2023

The pandemic also deeply impacted how industry and the government conduct their operations. A teleconference will be conducted by voice only with no projection of presentations or use of video/camera; a videoconference would involve sharing a screen so that a presentation can be viewed by all participants and/or involve the use of video.

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Relationship Government Screening Medical 53

FDA Law Blog

JUNE 7, 2023

The cases were both brought under the False Claims Act (FCA), the Civil War-era law that the government uses to claw back funds it pays out to parties that overbill federal programs. In this case, the Supreme Court provided greater clarity on how to interpret that requirement. What was SuperValu all about?

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Government Patient-Centered Manufacturing IT 40

FDA Law Blog

APRIL 21, 2024

Government—was that, despite having missed the statutory 60-day filing deadline, the patent was granted a PTE due to a change in the law created by Section 37 of the Leahy-Smith America Invents Act (“AIA”) ( Pub. . § The way that matter ended up—after touching all three branches of the U.S. That’s important, because PTE applications for U.S.

Provider 59

Provider IT Government 59

FDA Law Blog

MARCH 20, 2022

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. The Guidance provides practical guidelines for both firms and direct accounts. The Guidance emphasizes that firms need to be “recall ready.”

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law Blog

AUGUST 17, 2022

We note, however, that some of the most important clarifications are not codified in the actual rule but are presented in the Preamble; thus, while FDA currently plans to interpret the rule as it states in the Preamble, it is not bound to do so. FYI, FDA does not use the term “regular hearing aids,” but we are for simplicity.)

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Provider Manufacturing IT Government 40

FDA Law Blog

APRIL 23, 2021

The question presented is whether this statutory language authorizes the Commission to seek, and a court to award, equitable monetary relief such as restitution or disgorgement. Background on the case can be found in earlier posts here , here , here , and here. 592, 15 U. We conclude that it does not.

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Government IT Transportation Provider 40

FDA Law Blog

JUNE 27, 2024

The government’s expert testified that any red flag associated with a controlled substance prescription must be resolved and that resolution documented before dispensing. Coconut Grove had noted “verified” on the prescriptions which DEA found “is not sufficient to identify and resolve any red flags that may be present.” By Larry K.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

ABIM

JUNE 4, 2025

Dr. McDonald spoke about ABIM’s work engaging early career physicians (those who earned initial certification within the last 10 years), including presentations and listening sessions at recent national meetings. Community Practice in ABIM Governance* Erica N. He suggested a similar approach for APDEM’s annual meeting.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles. The group discussed some of Dr. McDonald’s updates in greater detail.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

JUNE 24, 2025

Gertz, MD, MACP, Chair, ABIM Hematology Board The Hematology Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on May 2, 2025. A representative from the American Society of Hematology (ASH) joined for a portion of the meeting*.

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Board-Certified Board-Certified Physicians Government Community 40

The Clinical Problem Solvers

FEBRUARY 14, 2022

Hosted by team members Naomi Fields and LaShyra Nolen,our guests present their community-based work in Pennsylvania and lay bare the connections between race, place, and health. Our ancestors considered our present to be impossible, so how can we use our ideas and experiences to effect positive change in our communities? Be curious.

Community 52

Community Individual Mental Health IT 52

FDA Law Blog

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.”

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Government Manufacturing IT Utilities 72

ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Rodriguez, MD , Chair of the Nephrology Board, and John C.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

FDA Law Blog

FEBRUARY 7, 2024

According to the eBay settlement agreement, the government contends that from October 2015 to the present, eBay did not comply with any of “the CSA’s reporting and recordkeeping obligations” involving thousands of transactions. 21 U.S.C. § It is unclear whether DEA had any conversations with eBay at that time.

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Government Electronics Education Individual 116

GeriPal

JUNE 19, 2025

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding. Can you tell me about that?

Individual 85

Individual Community IT Chronic Condition 85

GeriPal

JANUARY 20, 2023

There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. He’s a geriatrician and Chair of Public Policy for the California Association of Long-Term Care Medicine. Welcome back to the GeriPal podcast, Mike. I hope I got that right. Mike: You got it right.

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GeriPal

NOVEMBER 17, 2022

AlexSmithMD (still on Twitter at present). We additionally firmly establish that the song How to Save a Life by the Fray was a product of the aughts (2005, to be exact), not the 90’s ): Enjoy! Transcript. Eric: Welcome to the GeriPal podcast. This is Eric Widera. Alex: This is Alex Smith. And which journal again? Eric: JAMA Network Open.

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Community IT Mental Health Medical 97

GeriPal

APRIL 13, 2023

Check out some of their recent work, including: Dr. Holt-Lunstad’s and Dr. Perissinotto’s powerful perspective piece in the New England Journal of Medicine which provides a clinical framework for addressing loneliness and social isolation. Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. All right.

IT 99

IT Community Patient-Centered Medical 99

FDA Law Blog

OCTOBER 17, 2023

If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. Although not directly relevant, the FDA Innovation Challenge program called “ Devices to Prevent and Treat Opioid Use Disorder ” may provide you with an idea.

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